Access to Electronic Health Records by Sponsor representatives in clinical trials

The document provides guidance for Sponsors, Contract Research Organisations (CROs), and investigator sites on managing personal data processed in relation to research. It emphasizes the importance of protecting trial participants' data confidentiality and outlines expectations for provision of research monitor access to Electronic Health Records (EHR). The guidance recommends remote direct Log-in Access to EHR systems for monitoring and auditing, with controls implemented by both the sponsor and investigator site/institution to ensure security and privacy.